Norwegian doctors are planning larger study with Rituximab

The Bergen based doctors behind the norwegian ME breakthrough are now working on
executing a larger study with far more patients. If the financing gets in place, a study
of this kind could be an important step towards a treatment for ME.

In october TV2 dropped news about the norwegian breakthrough who might solve the
ME-riddle. The two oncologists Prof. Olav Mella and Dr. ystein Fluge based at
Haukeland uiniversity hospital Bergen discovered by coincidence a possible way to treat
ME, also known as chronic fatigue syndrome.

The doctors are now working towards a bigger multi center study with several university
hospitals in Norway. Such a study will be an important step against treatment for ME.

If the study turn out to be positive and show a clear effect and we dont have serious
unexpected complications then we are starting to get close to a proven treatment.
It will then benefit many people says ystein Fluge.

Big interest from the medical field

After the study got known many professionals have shown interest and contacted the
two men.
-Several of the university clinics have now taken initiative to start a national multicenter study on the effect of Rituximab in ME says Prof. Olav Mella to Tv2.no.

- Such a study will be based on the earlier study and a Rituximab maintenance treatment study which is going on a the moment at Haukeland. The doctors believe the study can be started sometime after summer next year.

- We dont want to rush it and we want to learn as much as we can from the maintenance study still going on says Fluge.

- The results from this study are not official yet but we already see some things regarding the number of infusions and response patterns. We want to use this knowledge in the next study.

Need financing

At the moment a study of this kind is still only in idea stage. The initiative is there but
the doctors are in need on financial support to make it become reality.

If this study is going to be made we are totally dependant on external financing. If we
just are going to base it on money from normal channels as the norwegian research council it will take forever before we can do something says Mella to Tv2.no

From where the funding should come from is still not clear but the doctors are hoping
that the norwegian state will back them.

We will atleast go into discussions with state officials about external financing says mella.
Tv2 have earlier been writing about minister of health Anne Grete Strm Erichsen who
promised to follow up on the ME breakthrough.

Strict inclusion criteria to join the study.

The interest from patients have been enormous and overwhelming for Fluge and Mella.
- I have received hundreds of emails and people are calling directly to my mobile says Fluge.

Now that you are working on a new study alot of people are probably wondering if they
can join. What can you say about the inclusion criteria?

If we are to have a good study we need to have very clear criteria. They have to be crystal clear, says Mella.

It is especially important because there will be different doctors at different centers who
will care for the patients. Fluge and Mella want to use the so called Canadian criteria.

We want to go for the strict criteria. We want that the chance for the patients in the study really have ME to be as big as possible and not general fatigue, says Fluge.
He also points out that it is in everybodys interest that they have a strict screening process.

If the study turn out to be positive and show clear efficacy and serious complications does not arise, we are getting closer to making this a proven treatment in ME.
It will then benefit many patients, says Fluge to Tv2.no.